Stroke system of care trial: a cluster randomised trial evaluation of a patient and carer-centred system of Longer-Term Stroke Care

ISRCTN	ISRCTN67932305
DOI	https://doi.org/10.1186/ISRCTN67932305
Secondary identifying numbers	RP-PG-0606-1128

Submission date: 04/04/2008
Registration date: 09/05/2008
Last edited: 13/07/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Anne Forster
Scientific

Academic Unit of Elderly Care and Rehabilitation
Bradford Institute for Health Research
Temple Bank House
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

Phone	+44 (0)1274 383 406
Email	a.forster@leeds.ac.uk

Study information

Study design	Pragmatic multi-centre cluster randomised controlled trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Community
Study type	Quality of life
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Stroke system of care trial: a cluster randomised trial evaluation of a patient and carer-centred system of Longer-Term Stroke Care
Study acronym	LoTS Care
Study objectives	The hypothesis for LoTS Care is that a system of care delivered by a Stroke Care Co-ordinator (SCC) to patients and carers living at home, in the community, will improve psychological and functional outcomes compared to usual SCC practice. The primary objective of the trial is to determine whether the system of care improves psychological outcomes for patients requiring long term care at home. The secondary objectives include: 1. Improved functional outcomes for patients requiring long-term support at home 2. Improved psychological and functional outcomes for carers of patients requiring long term support at home 3. Cost effectiveness
Ethics approval(s)	Leeds (West) Research Ethics Committee, 09/05/2008, ref: 08/H1307/43
Health condition(s) or problem(s) studied	Stroke
Intervention	Stroke services will be randomised into intervention or control groups using the stratification factors of quality of the stroke unit; referral rate and SCCs working alone versus within a community multidisciplinary team. SCCs in stroke services randomised to the intervention group will be trained to deliver a system of care centered on key problems identified as of central importance to stroke patients and their carers. The assessment schedule is presented in a manual comprising 16 questions (patient) and 11 questions (carer) representing the identified problem areas, linked to reference guides containing educational text with algorithms of evidence based treatment options and associated patient carer action plans. Implementation of the assessment system is supported by a specific training programme. SCCs in stroke services randomised to the control group will continue to deliver current community-based practice as determined by local policy and practice. The SCC will undertake a primary assessment of patients (and carer if appropriate) using the system of care and instigate service responses, with additional follow-up and monitoring visits as appropriate to the needs of individual patients. Therefore there are no specified treatment times for either arms. Follow up of both the control and intervention arms of the patients (and carers if applicable) will be followed up at 6 and 12 months.
Intervention type	Other
Primary outcome measure	General Health Questionnaire 12 (GHQ12) completed by the patient 6 months after recruitment
Secondary outcome measures	The secondary outcome measures for patients at 6 and 12 months are: 1. Frenchay Activities Index 2. Barthel Index 3. EQ-5D 4. Stroke Impact Scale 5. Longer-term Unmet Need in Stroke 6. Satisfaction 7. Death 8. Hospital re-admission 9. Institutionalisation 10. Total costs 11. Cost-effectiveness/cost-utility The GHQ12 at 12 months is also a patient secondary outcome measure to assess whether any intervention effect is sustained. The secondary outcome measures for carers at 6 and 12 months are: 1. GHQ12 2. Carer Burden Scale 3. Satisfaction 4. Death 5. Institutionalisation
Overall study start date	01/06/2008
Completion date	30/04/2012

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	800 patients (and carers if applicable)
Key inclusion criteria	The trial is evaluating a complex intervention delivered by the Stroke Care Co-ordinator (SCC) within a stroke service and eligibility criteria apply at three levels - the stroke service, the stroke unit and the SCC. A stroke service will only be considered for inclusion in the trial if it includes a stroke unit which fulfils the Royal College of Physicians guidelines definition of a stroke unit, that is, by the presence of 4/5 of the following criteria: 1. Consultant physician with responsibility for stroke 2. Formal links with patient and carer organisations 3. Multidisciplinary meetings at least weekly to plan patient care 4. Provision of information to patients about stroke 5. Continuing education programmes for staff Stroke Care Co-ordinators (SCC) will be eligible if they fulfill the following criteria: 1. A registered healthcare professional with documented experience in stroke care 2. Undertakes a community based liaison or co-ordinating role for stroke patients 3. Co-ordinates a range of longer-term care inputs on the patients' and carers' behalf (e.g., signposting, carrying out assessments) 4. Works within a stroke service as above Patients with the following characteristics will be eligible for the trial: 1. Have a confirmed primary diagnosis of stroke 2. Are referred to a SCC on discharge home from hospital or within six weeks of stroke 3. Are still waiting for their first SCC assessment visit 4. Provide written informed consent or carer assent All carers with the following characteristics are eligible for this study: 1. Identified by the patient 2. Eligible for this study 3. Provides the patient with practical support on at least a weekly basis
Key exclusion criteria	Patients will be excluded from the trial if: 1. They are unlikely to survive for more than three months 2. Are being discharged to/resident in a nursing or residential home 3. Have been previously registered to the trial 4. They are taking part in other stroke research network adopted studies which involve 6- and 12-month follow-up questionnaires
Date of first enrolment	01/06/2008
Date of final enrolment	30/04/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Bradford Institute for Health Research

Bradford
BD9 6RJ
United Kingdom

Sponsor information

Bradford Teaching Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

c/o John Wright
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
England
United Kingdom

Phone	+44 (0)1274 364279
Email	j.wright@bradfordhospitals.nhs.uk
Website	http://www.bradfordhospitals.nhs.uk/
"ROR"	https://ror.org/05gekvn04

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Stroke Association
Private sector organisation / Associations and societies (private and public)

Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2014		Yes	No
Results article	results	01/08/2015		Yes	No